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Drug Safety Update - May 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for May 2020 (PDF).

This month clinicians are advised of a new dedicated COVID-19 Yellow Card reporting site for medicines and medical devices. The site aims to allow rapid identification of new and emerging side effects and medical device incidents in COVID-19 treatment, including side effects for medicines taken by patients to manage long-term or pre-existing conditions.

Readers are also advised of the temporary guidance to specialists regarding the Valproate Pregnancy Prevention Programme during the coronavirus (COVID-19) pandemic and also temporary advice for management of certain immunomodulatory drugs (thalidomide, lenalidomide and pomalidomide) and the associated pregnancy prevention programme.

The summary of letters to healthcare professionals includes details of a recall of Emerade®, safety letters about change in presentation of ReQuip® and new restrictions in the use of cyproterone acetate and several letters regarding supply contrataints.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.